Capsule Shell

Capsule Shell

A capsule shell is an outer skin in which a medicinal substance is contained. The capsule shell acts as a container for the medicine and protects it. These capsule shells contain gelatin and should dissolve in the mouth.
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Technical Parameters
The Best Capsule Shell Manufacture!

 

Zhejiang Tianlong Capsule Co., Ltd. is a professional manufacturer of hollow capsules. We mainly produce 00#, 00#B, 0#el, 0#, 1#, 2#, 3#, 4# and other specifications of gelatin hollow capsules and plant capsules. At present, the company has two capsule production plants and installed 46 hollow capsule production lines,the current annual production capacity has reached 26 billion capsule.

 

Why Choose Us
 

Raw Materials
We offer a vertically integrated supply chain model to ensure reliable long-term supply, complete traceability, and superior quality of raw materials. Our raw materials pass through strict quality control assessments before going to the manufacturing stage.

 

Complete Qualifications
Our plant area is strictly planned and designed according to the GMP standard for pharmaceutical excipients. We have passed ISO9001, USFDA, HALAL quality management system certification and is registered with the FDA in the United States.

 

OEM & ODM Service
We can provide hundreds of colors for customers to choose, but also in accordance with the customer's color card number and sample custom production.

 

Quality Guaranteed
Advanced automated equipment and facilities, strict indoor cleanliness procedures and perfect quality real-time monitoring, as well as high-quality raw materials to ensure that customers can provide quality products at any time.

 

Empty HPMC Capsule

Empty HPMC Capsule

Low water content, suitable for water sensitive components. No risk of cross-linking reaction. The structure of elastic polymer ensures the stability of the capsule and the high filling rate.

Hydroxypropyl Methylcellulose Capsule

Hydroxypropyl Methylcellulose Capsule

Custom pharmaceutical grade drug in Halal natural plants cellulose print colored empty hard vegetable HPMC capsules

HPMC Vegetarian Capsule

HPMC Vegetarian Capsule

Our high quality, high performance HPMC(hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

Empty Veggie Capsule

Empty Veggie Capsule

Zhejiang Tianlong Capsule Co., Ltd. was founded in 1987 and is a professional manufacturer of hollow capsules. At present, the company has two capsule production plants and 46 hollow capsule production lines installed.

Vegetarian Capsule

Vegetarian Capsule

Low water content, suitable for water sensitive components. No risk of cross-linking reaction. The structure of elastic polymer ensures the stability of the capsule and the high filling rate.

Vegetable Capsule Shell

Vegetable Capsule Shell

Halal food refers to food that meets Islamic Halal food standards. Islamic eating habits come from the canon. According to the canon, halal foods do not contain contraindications such as dead objects, blood and pork.

Cellulose Capsule

Cellulose Capsule

Function/ The stomach dissolves, disintegrates, dissolves and absorbs rapidly in the stomach. Advantages/ Low moisture content, no fragility, suitable for moisture-sensitive or hygroscopic content, such as plant source content. Suitable for all people.

Vegan Gelatin Capsule

Vegan Gelatin Capsule

Our high quality, high performance HPMC(hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

Hollow Capsule

Hollow Capsule

Our high quality, high performance HPMC (hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

 

What Is Capsule Shell

 

 

A capsule shell is an outer skin in which a medicinal substance is contained. The capsule shell acts as a container for the medicine and protects it. These capsule shells contain gelatin and should dissolve in the mouth. A capsule shell is an outer skin in which a medicinal substance is contained.

 

Difference Between Soft Gelatin And Hard Gelatin Capsule

 

1. Soft gelatin capsules can perhaps function more quickly than other types of capsules because they dissolve easily in the gastric juices of the stomach.
A soft gelatin capsule is used to contain medication that is in the form of a liquid or powder because it dissolves more rapidly than a hard gelatin capsule.
2. When compared to soft gelatin capsules, which are sealed up one-piece capsules that cannot be detached, hard gelatin capsules feature two distinct parts: a body and a cap.
3. Soft gelatin capsules normally hold liquids and semisolids while hard gelatin capsules frequently contain dry powders, plugs that have been slightly compressed, granules, or tablets.
4. While soft gelatin capsules come in round, oval, and tubular shapes, hard gelatin capsules are cylindrical.
5. A hard gelatin capsule contains less plasticizer than a soft gelatin capsule.
6. While the production of hard shell capsules requires two separate machines-one for the shells and another for the filling-the production of soft gelatin capsules only requires one equipment for the feeding and sealing steps.

 

 
Capsule Manufacturing Process: Step By Step Guide

 

Step

Process Description

Key Considerations

Formulation Development

Design the active pharmaceutical ingredients (API) and excipients to create a stable formulation.

Ensure compatibility between API and excipients. Consider bioavailability and dosage form.

Raw Material Sourcing

Procure high-quality raw materials (API, excipients, gelatin, etc.) from verified suppliers.

Supplier qualification, raw material testing for purity, potency, and quality.

Blending

Mix API and excipients uniformly to ensure consistency in dosage.

Homogeneity is critical; over-mixing can affect the quality.

Granulation

Convert the blended powder into granules to improve flowability and compressibility.

Two methods: wet granulation and dry granulation; consider moisture content.

Capsule Shell Preparation

Prepare gelatin or alternative materials (e.g., HPMC) for the capsule shells.

Ensure proper viscosity and temperature during gelatin processing.

Capsule Filling

Fill the prepared capsules with the blended formulation using a capsule filling machine.

Adjust the machine for accurate dosage and minimize product loss.

Capsule Sealing

Seal the capsules, especially for liquid or semi-solid formulations, to prevent leakage.

Use banding or other sealing techniques as required.

Quality Control Testing

Test the filled capsules for weight variation, disintegration, dissolution, and content uniformity.

Follow pharmacopeial guidelines and ensure all batches meet quality standards.

Polishing and Inspection

Polish the capsules to remove any dust and inspect for defects like cracks, dents, or color variation.

Automated or manual inspection to ensure visual and structural integrity.

Packaging

Pack the capsules in blister packs, bottles, or bulk containers under controlled conditions.

Protect from moisture, light, and oxygen; ensure proper labeling and documentation.

Storage and Distribution

Store the packaged capsules in controlled conditions and distribute to the market.

Maintain proper temperature and humidity; ensure compliance with regulatory standards.

 

Types of Capsules in Pharmacy
 

Gelatin Capsules

Gelatin capsules are categorized into hard and soft shells. These shells are made using different manufacturing processes and usually have different shell designs; they all provide an effective and protective cover from light and atmospheric conditions for medicines or supplements. Here's a detailed overview of each type of gelatin capsule.

Modified Release Capsules

Modified release pharmaceutical capsules or dosage forms are used in capsules to dissolve a medicine, vitamin, or supplements over time in order for the ingredients to be released slowly and steadily into the bloodstream. This process can be carried out for both hard and soft gelatin capsules, and it is administered less frequently than immediate-release dosages.
What is the purpose of modified-release tablets The purpose or need for this type of administration is to control the rate at which the ingredients in the dosage are released into the bloodstream. Besides that, they are also used to maintain a specific concentration of the substance in your blood to help healthcare practitioners achieve various objectives.

Enteric Capsules

Once a medication is administered orally, it can be easily broken down by stomach acids before it passes through the intestine and is distributed to the areas experiencing symptoms via the bloodstream. To prevent this absorption from happening in the stomach, enteric coating, which is used during oral delivery of medicines, vitamins, and supplements, degrades quickly in the stomach, preventing the ingredients from being released until they get to the intestine.

Vegetarian Capsules

Unlike gel capsule types, which are made from animal bones, skin, and cartilage, vegetarian capsules or veggie caps are made up of cellulose-a complex polysaccharide that forms the principal component of the plant cell wall. Since these shells are made from vegetables, they are ideal for people who do not eat fish, meat, and other animal products.

 

Packaging and storage - how gelatine reacts to relative humidity
 

When capsules are packaged, attention should be given to the ambient conditions, as a small quantity of the surrounding air will be sealed in with the product. Depending on the volume of the packing container, this could introduce a quantity of water vapor that may affect the capsules. In general, HPMC capsules are not as vulnerable to this water vapor as gelatine capsules are, so from this point on only gelatine capsules will be considered.
Table 1 shows the effect on the melting point of gelatine films stored at various relative humidity levels after conditioning at 50°C for eight days. The melting point/dissolution temperature of the gelatine film was determined by placing the film in a water bath at 20°C, and the temperature was raised by 1.7°C per minute until the gelatine dissolved. It is interesting to note that the initial melting point of the samples was 32°C, which correlates to the gelatine samples that were stored in low humidity conditions.
At a relative humidity level of 85%, the maximum change in melting point is observed; excessive moisture absorption at higher levels increases the separation between gelatine molecules and makes reformation of bonds more difficult. Increased melting point is a problem, as the gelatine will not dissolve as expected when the patient ingests the capsules.

Capsule Shell

 

Why Are Gelatin Hard Capsules Preferred Over Other Formats

 

 

Like their softgel counterparts, gelatin hard capsules offer value to consumers and producers alike. These advantages are due largely due to their main component, gelatin. Gelatin means "stiff" and is a colorless dry powder that has been used for centuries in a host of food and pharmaceutical uses. For consumers, gelatin dissolves in the human body at normal body temperature, making it the ideal ingredient in hardcaps. While protecting the precious actives inside the capsule against oxygen, light, moisture and dust, the gelatin of the hardcaps affords consumers easy swallowing. Consumers also appreciate that the capsule size and color can help them to more easily identify the respective pharmaceutical drug or nutrient inside. For producers, gelatin provides fast machinability and setting times, ideal dissolution properties and an optimal protection of fill ingredients. Producers can then market the empty hard gelatin capsules to brand owners who are filling with medications or nutrients. reputable gelatin suppliers offer Halal and Kosher certifications for different gelatin types to satisfy wide-ranging consumer requirements and preferences. Hard gelatin capsules also allow easy filling.

 

Preventing Moisture Induced Damage In Soft Gelatin Capsule Production

 

Gelatin capsules hold an important place in the pharma industry. It is highly preferred for its versatility in the form of elasticity and features clarity, the ability to melt at body temperature, along with thermoreversible flexibility. Soft gelatin is widely sought for non-allergic properties backed up with safety and non-toxic profile. Additionally, the proteins making up the gelatin render the capsule to be easily digestible and swallowed effortlessly.
But even against the endless list of advantages, gelatin, as a material, is highly sensitive to moisture and temperature. Moisture can lead to the spoilage of capsules and make the entire manufacturing process a challenging task. In the presence of high levels of humidity, the capsules are vulnerable to become brittle, melt and show resistance in solidifying into a band. In severe cases, the high relative humidity (RH) accounts for undesirable microbial contamination that invariably deteriorates the capsule quality.
This mandates the close monitoring of air entering the dryer throughout the manufacturing and drying processes. The air should be thoroughly conditioned to achieve acceptable temperature and humidity levels. The humidity threat can be understood through the manufacturing process. In this, warm liquid gelatin is spread over a slowly revolving stainless-steel drum, following this, chilled dry air is supplied for congealing the gelatin into a tacky, elastic band. In the process, the thin band is automatically molded into a capsule filled with medicine inside. During the entire process, if the temperature and humidity are beyond unacceptable levels, then the soft gelatin fails to solidify and remains soft. In turn, the soft moist capsules are shifted from encapsulating machines to drying drums or chambers for carrying out rapid drying.
Looking at the vulnerability of soft gelatin capsules to moisture, it is imperative that manufacturers install desiccant dehumidifiers to get rid of the unwanted humidity from the air. As gelatin has a soft texture, drying the capsule becomes a tricky job. Temperature and humidity conditions must meet the crucial specifications that must not exceed 20 in both cases. The humidity level needs to be maintained in the range of 30±5% at 23°C for the encapsulation and packing processes. Likewise, even during the drying process, the humidity level needs to be kept within the range of 15±5% at 20°C. It is very crucial to abide by the specific air changes and laminar airflow while complying with the time limit for administering uniform drying. Inability to meet the required specifications results in the production of substandard capsules. Here, P95x dehumidifiers are specially crafted to meet the extreme cleanliness and hygiene standards of the pharma industry. It is highly efficient at saving more than 30 per cent energy owing to its regenerating capacity at 95 degrees Celsius. The novel adsorbent, G4 desiccant rotor technology is at the heart of it all.
Not just during manufacturing, but utmost care must be taken when hygroscopic materials are air-veyed from storage to processing areas. The transfer must be mediated in dehumidified conditions to refrain the capsules from regaining moisture during the filling and packaging operations. Considering the varied requirements to be fulfilled, the desiccant dehumidification solution is the ideal technology that is highly efficient in meeting the most complex and stringent humidity/moisture control requirements during capsule manufacturing. The advanced technology achieves optimum moisture level at a very low dew point throughout the production, storage and transportation processes. It fulfills the role of protecting the raw material from moisture menace, and, at the same time, also achieves the highest hygienic conditions all round the year, unaffected by the ambient environment around.
Apart from manufacturing, even storage requires low humidity conditions to avoid any instance of moisture regain that can ruin the entire effort gone into manufacturing the product. As a result, the packaging of gelatin capsules are done in aluminium foil storage which provides a humidity-controlled environment for the moisture-sensitive capsule.
Considering that the quality of gelatin capsules is imperative for the well-being of humans, the drugs must be manufactured with the purpose to elevate the health of humans. Therefore, dehumidification solutions must be installed invariably in the manufacturing infrastructure of the gelatin capsules.

 

 
Our Certificates

 

We always feel that all success of our company is directly related to the quality of the products we offer. They meet the highest quality requirements as stipulated in ISO9001, USFDA, HALAL and our stringent quality control system.

 

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Automatic Production Plant

 

The plant area is strictly planned and designed according to the GMP standard for pharmaceutical excipients.

 

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FAQ

 

Q: How long does a capsule stay in your stomach?

A: The capsule will normally leave the stomach within four hours of swallowing, so eating is not allowed during this time so that the capsule does not mix with food, which obstructs the view. It is, however, permissible to drink clear fluids two hours after swallowing the capsule.

Q: Is capsule coating safe?

A: First of all it's not plastic. It may look like it but it is actually gelatin. Gelatin breaks down in your stomach and passes through your system like any other food. Unless you are allergic or sensitive to the ingredient used to make the capsules then they're not anymore dangerous than anything else you would eat.

Q: How long does it take for a capsule shell to dissolve?

A: A standard gelatin hard capsule dissolves in the stomach, under normal conditions, within twenty to thirty minutes after swallowing. Depending on the application, different gelatin types or additional process steps can influence the dissolution process.

Q: What are the side effects of capsule shell?

A: However, capsules made from gelatin carry some side effects too. They are reported to cause indigestion, upset and bloated stomach, hypersensitivity, exposure to toxins leading to gastric problems, and their excessive consumption can also cause kidney and liver damage.

Q: Are capsule shells digestible?

A: Depending on their contents, capsules made be hard shelled or soft shelled. The capsules are made of gelatin and not plastic. the same will be digested in our stomach.

Q: What are capsule shells made of?

A: Capsule, a form of dosage form in medication, are common in our day-to-day health management. Capsules are made up of gelatin (hard or soft) and nongelatin shells generally derived from hydrolysis of collagen (acid, alkaline, enzymatic, or thermal hydrolysis) from animal origin or cellulose based.

Q: Why are capsules coated with plastic?

A: This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach (usually in the upper tract of the intestine). Some drugs are unstable at the pH of gastric acid and need to be protected from degradation.

Q: Is it safe to break open a capsule?

A: Advice from the NHS is not to crush pills, open capsules or alter your medicine without getting medical advice as this could stop the medicine working properly.

Q: What preservatives are in capsule shell?

A: A preservative, such as beta-naphthol, may be added to inhibit bacterial growth on the gelatin. Colouring agents and opacifiers may also be added as well as sweetening agents. The thickness of the gelatin depends on the material to be encased within the capsule and the temperature and humidity of the surroundings.

Q: What is the melting point of capsule shell?

A: The most common material used for capsule production is gelatine. Regardless of the source and type of gelatine, the actual physical characteristics of different types of gelatine are similar from a drying and storage perspective. For example, the melting point of all types of gelatine is around 30°C to 32°C.

Q: Do capsules dissolve in your stomach?

A: Releasing the capsule's ingredients commencing when the capsule's shell degrades. Conventional gelatin hard capsules, enter the stomach in one to 5 min. The capsule's shell begins to degrade due to gelatin's sensitivity to the stomach's acidic environment and release the drug.

Q: What happens if a capsule breaks in your mouth?

A: The clinical consequences for the patient of crushing tablets or opening capsules can be serious: alteration of the drug's absorption can result in sometimes fatal overdose, or conversely underdosing, rendering the treatment ineffective.

Q: Can we eat capsules without cover?

A: It's not advisable to open a capsule pill unless you're advised to do so by a doctor or other medical professional. They may need to be swallowed whole because: They're designed to release medicine slowly into your body over time and crushing them could cause an overdose.

Q: What are the benefits of capsule shells?

A: Gelatin is widely used to create the shell for both hard and soft capsules, providing an effective means of protecting the contents from light, atmospheric oxygen, contamination and microbial growth as well as masking taste and odor.

Q: Can I remove a capsule shell?

A: In general, it is okay to break or open a vitamin or other supplement, either by splitting or crushing a tablet, or twisting open a capsule, unless directions say not to or if it is an extended-release, timed-release, or enteric coated pill.

Q: Can capsules be exposed to air?

A: If you do not keep medication correctly, pills may be damaged or expire faster, which can make them unsafe to take. Exposure to air, light or moisture can all damage your medication so it's essential you know how to store them correctly.

 

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